Regeneron and Sanofi’s Dupixent has received FDA approval for COPD, marking a significant advancement in treating this chronic lung condition. This targeted therapy addresses type 2 inflammation pathways, offering hope for patients with frequent exacerbations and improved lung function.
Results for: Regeneron
Regeneron Pharmaceuticals has appealed a court decision that allowed Amgen to proceed with the sale of its biosimilar version of Eylea, a blockbuster drug for eye conditions. The move comes after Regeneron failed to secure a preliminary injunction to block Amgen’s biosimilar, Pavblu, from entering the market.
Regeneron Pharmaceuticals and Sanofi announced positive results from multiple Phase 3 trials of their drug Dupixent, demonstrating its effectiveness in treating chronic skin conditions like chronic spontaneous urticaria (CSU) and bullous pemphigoid. These findings could lead to expanded approval for Dupixent to treat a wider range of skin conditions.
Regeneron Pharmaceuticals has received European Commission approval for its drug Ordspono (odronextamab) for treating adult patients with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma. This approval is a significant win for the company, following a setback in the US. However, the company faces challenges in the US market as it works to overcome regulatory hurdles for its oncology drugs.
Regeneron Pharmaceuticals has faced a setback with the FDA rejecting its application for linvoseltamab, a treatment for a form of blood cancer. The rejection was due to issues related to a pre-approval inspection of a third-party manufacturer. Despite the setback, Regeneron remains committed to bringing linvoseltamab to patients, working closely with the manufacturer and the FDA.